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OpenTrials
Completed

NCT Number: NCT00649909

Effect of Glucose Control on the Response to Aspirin in Type 2 Diabetic Patients

The efficacy of low dose aspirin appears to be substantially lower in diabetic patients, compared to patients without diabetes.

We will perform an observational study where we follow up patients with uncontrolled type 2 Diabetes Mellitus and low response to aspirin (Aspirin Resistance), during a period of 6 months in the diabetic clinic. Our hypothesis is that glucose control will improve the response to aspirin in those patients.

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Key information

Conditions

Diabetes Mellitus, Type II Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hadassah Medical Organization

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 DM.
  • Patients that take aspirin.
  • Antecubital forearm veins allowing technically good sampling for platelet studies.
  • Reduced Laboratory response to aspirin.
  • HbA1c > 8 %
  • The physician decides that there is an indication for glucose control.

Exclusion criteria

  • Acute ischemic stroke, acute coronary syndrome, (myocardial infarction or unstable angina pectoris), or revascularization by PCI or by-pass surgery within the last 6 months.
  • Acute kidney disease or chronic kidney disease with creatinine clearance <30.
  • Acute liver disease or chronic liver disease with severe liver impairment.
  • Need for treatment with anticoagulants, clopidogrel, NSAID's, or thiazolidinediones.
  • Thrombocytopenia (platelet count <150 x 109/L)

Treatment and study plan

Primary outcomes

  1. The outcome measure is the laboratory Aspirin Resistance.

    Time frame: 3 and 6 months.

Secondary outcomes

  1. To determine the incidence of laboratory aspirin resistance in type 2 DM in stable out-patients in the diabetic clinic, and possibly related factors.

    Time frame: On screening visit.

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 1, 2008
Registry last updated
Aug 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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